Using ultrasound to measure the angle of progression to reduce cesarean deliveries
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.
This study is testing if using ultrasound to measure the angle of progression during labor can help lower the number of cesarean deliveries for women who are unsure about their baby's position.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital St. Joseph, Marseille, France Academic / other |
| Locations | 7 sites (Lille and 6 other locations) |
| Trial ID | NCT05779735 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the effectiveness of measuring the angle of progression (AOP) using transperineal ultrasound during labor to decrease the cesarean delivery rate. It builds on previous findings that suggested a significant reduction in cesarean rates when AOP measurements were used alongside digital examinations in prolonged second stages of labor. The study will involve nulliparous and multiparous women with specific eligibility criteria, focusing on those with uncertain fetal head engagement. By conducting a multicenter randomized trial, the researchers hope to confirm the benefits observed in earlier pilot studies.
Who should consider this trial
Good fit: Ideal candidates include nulliparous or multiparous women with no history of vaginal delivery, at least 37 weeks pregnant, and with a cephalic presentation in anterior position.
Not a fit: Patients who have had previous vaginal deliveries, are carrying twins, or have fetal heart rate abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the cesarean delivery rates among women experiencing prolonged labor.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this validation study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous or multiparous women with no history of vaginal delivery, * \> or = 37 weeks amenorrhoea * Cephalic presentation in anterior position (occipito-pubic position, left anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound * uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours), Exclusion Criteria: * Multiparous women who were previous vaginal deliveries, * Presentation other than cephalic, * Twin pregnancies, * Posterior or transverse position * Transperineal ultrasound for head-perineum distance measurement * Fetal heart rate abnormalities requiring rapid delivery, * Contraindication to vaginal delivery whether maternal or fetal
Where this trial is running
Lille and 6 other locations
- CHU de Lille - Hôpital Jeanne de Flandre — Lille, France (Recruiting)
- APHM Hôpital Conception — Marseille, France (Recruiting)
- Hopital Saint Joseph — Marseille, France (Recruiting)
- APHM Hôpital Nord — Marseille, France (Recruiting)
- Hôpital Armand Trousseau AP-HP — Paris, France (Recruiting)
- CHIC Poissy — Poissy, France (Recruiting)
- CHITS Hôpital Sainte Musse — Toulon, France (Recruiting)
Study contacts
- Principal investigator: Jean-Baptiste Haumonte — Hopital Saint Joseph Marseille
- Study coordinator: Rahamia Ahamada
- Email: rahamada@hopital-saint-joseph.fr
- Phone: 0033488731071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.